An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Palo Alto, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02253992
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced B-cell NHL
  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urelumab — BIOLOGICAL
  • Nivolumab — BIOLOGICAL

Study Details

The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

Key Dates

Start date
Sep 29, 2014
Status verified
Sep 2020
Primary completion
May 24, 2019
Completion
May 24, 2019

Study Design

Enrollment
232 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Cohort expansion: Urelumab + Nivolumab
    Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles

Primary Outcome Measure

The Incidence of Adverse Events. [ Time Frame: From day 1 until 100 days after participant last dose of study drug. ]

Locations (11)

FacilityCityStateZIPSite coordinators
Stanford University School Of MedicinePalo AltoCalifornia94304-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
University Of ChicagoChicagoIllinois60637-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterLuthervilleMaryland21093-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering NassauNew YorkNew York10065-
NYU Langone Medical CenterNew YorkNew York10016-
Providence Portland Medical CenterPortlandOregon97213-
UPMC Cancer CenterPittsburghPennsylvania15213-
Md AndersonHoustonTexas77030-

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